Test Equipment and Method Validation Engineer

ConvaTec Inc.; Reynosa; Presencial; MXN 420.000 - 540.000; Jornada completa

Descripción de la vacante

Convatec is seeking a Validation Engineer to validate and qualify processes and equipment. You will work with QA, Regulatory Affairs, R&D, suppliers, and production units to ensure compliance and robust validation practices.

The role requires a Bachelor’s degree in engineering and about 2 years of validation experience, with strong statistics knowledge and English proficiency. Cleanroom experience is a plus and collaboration across functions is essential.

Formación

• Bachelor's degree in Industrial Engineering, Process Engineering or related field.
• Approximately 2 years of experience in validation processes, calibrations and risk assessment.
• Basic knowledge and experience of statistical techniques.
• Experience in cleanroom preferred.
• Advanced English proficiency; Microsoft Office skills (Intermediate-Advanced).

Responsabilidades

• Validation and qualification of processes and equipment.
• Contribute to requirement specification, purchase and implementation of equipment.
• Establish and maintain local validation procedures and forms in line with current guidelines.
• Develop and maintain a Validation Master Plan (VMP) for re-validation.
• Coordinate with Maintenance, Production and Engineering for resource planning.
• Ensure high quality of equipment and documentation.
• Share knowledge across project teams and departments.
• Provide training on test equipment and validation methods.

Conocimientos

Validation processes

Calibrations

Risk assessment

English proficiency

Microsoft Office

Educación

Bachelor's degree in Industrial Engineering, Process Engineering or related

Descripción del empleo

About the role

As our new Validation Engineer you will be responsible for validation and qualification of processes and equipment. You will collaborate closely with cross-functional project teams, and key stakeholders like QA, Regulatory Affairs, R&D, suppliers, and the production units.

Key responsabilities

• Validation and Qualification of processes and equipment.
• Contribute to requirement specification, purchase and implementation of equipment.
• Establish/maintain necessary local procedures, instructions, and forms for validation test equipment in compliance with current BUID procedures for process validation and relevant quality standards, incl. GHTF (Global Harmonization Task Force) guidelines for process validation.
• Establish/maintain VMP (Validation Master Plan) for re-validation of test equipment & method, including validation history and ensure it is approved by and communicated to relevant areas.
• In cooperation with the Maintenance, Production and Eng. Department ensure resource planning for revalidation activities.
• Ensure high level of expertise and quality to the equipment and documentation.
• Contribute to knowledge sharing across project teams and departments.
• Ensure necessary training of employees in test equipment and method validation..

Requirements

• Bachelor’s degree in Industrial Engineering, Process Engineering or related.
• Approximately 2 years of experience working with validation process, calibrations and risk assessment.
• Basic knowledge and experience of statistic techniques is required.
• Experience in cleanroom preffered.
• English proficiency: Advanced required Microsoft profiency: Intermediate - Advanced.

Equal opportunities Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Already a Convatec employee? If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care.

With over 10,000 colleagues, we provide products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention, treatment for hard to heal wounds, at-risk skin and ulcerated tissue to supporting debilitating conditions, improved patient outcomes and reduced care costs. Convatec's revenues in 2025 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit: http://www.convatecgroup.com.

Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions, with leading market positions in advanced wound care, ostomy care, continence & critical care, and infusion care. Our products provide a range of clinical and economic benefits including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care.

If you would like to know how we intend to use your data following your application please refer to our full data privacy policy on the following link: https://www.convatecgroup.com/privacy-policy/